Apparatus for applying surgical fasteners to body tissue

ABSTRACT

An apparatus for endoscopic application of surgical staples adapted to attach surgical mesh to body tissue includes a frame and an elongated endoscopic section connected to the frame-and extending distally therefrom. A staple storage cartridge is removably supported on a pivotal support system at the distal end portion of the endoscopic section. An elongated pusher system is provided for individually advancing at least one staple at a time distally. The pusher system includes a trigger system to actuate the pusher. The trigger system is provided with perceptible tactile sensing means to indicate when the legs of the staple being advanced are exposed so as to be visible to the user for positioning and orientation purposes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.11/978,852, filed on Oct. 30, 2007, now U.S. Pat. No. 7,681,772, whichis a continuation of U.S. patent application Ser. No. 10/753,248, filedon Jan. 8, 2004, now U.S. Pat. No. 7,624,903, which is a continuation ofU.S. patent application Ser. No. 09/957,620, filed Sep. 20, 2001, nowabandoned, which is a continuation of U.S. patent application Ser. No.08/959,644, filed on Oct. 28, 1997, now abandoned, which is acontinuation of U.S. patent application Ser. No. 08/714,911, filed onSep. 17, 1996, now abandoned, which is a continuation of U.S. patentapplication Ser. No. 08/540,728, filed on Oct. 11, 1995, now abandoned,which is a continuation of U.S. patent application Ser. No. 08/318,585,filed on Oct. 5, 1994, now abandoned, which is a continuation of U.S.patent application Ser. No. 07/861,065, filed on Mar. 31, 1992, now U.S.Pat. No. 5,364,002, which is a continuation-in-part of U.S. patentapplication Ser. No. 07/782,290, filed on Oct. 18, 1991, now U.S. Pat.No. 5,289,963, and the disclosures of each of the above-identifiedapplications are hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an apparatus and method for applyingsurgical staples to attach objects to body tissue. More particularly,this invention relates to a staple applier particularly adapted forattaching surgical mesh to body tissue to reinforce a surgical repair ofthe body tissue, as in hernia repair.

2. Background of the Invention

Hernias may be divided into three general classes: direct hernia,indirect hernia and femoral hernia. In a direct or indirect inguinalhernia, often a part of the intestine protrudes through a defect in thesupporting abdominal wall to form a hernial sac requiring surgery whichgenerally includes a surgical incision in the groin ranging up to sixinches in length. Several layers of the abdominal wall are generallyseparated to reach the herniated portions. During the procedure, thehernia is closed outside the abdominal wall in a manner which resemblesthe tying of a sack at the neck. Often a surgical mesh is attached bysutures directly over the hernia repaired opening to provide areinforcement to the opening.

Traditionally, such hernia repairs involved major invasive surgicalprocedures which often caused excessive trauma to the patient andnecessitated unusually long post-operative recuperative periods. Inaddition, numerous complications, related directly or indirectly to thesurgery often resulted, including bleeding, infection, testicularatrophy, organ damage, nerve damage, blood vessel damage, etc. Further,cutting through the numerous layers of tissue to obtain access to theherniated area often caused severe trauma to the patient. A detaileddiscussion of traditional hernia repair may be found in “Hernia RepairWithout Disability, Second Edition”, by Irving L. Lichtenstein.

Such invasive surgical procedures have also been utilized in other areasof the body, including surgery on the gall bladder, appendix, lungs andthe like. For the reasons previously stated, the use of laparoscopic andendoscopic surgical procedures have been relatively popular and suchpopularity has provided additional incentive to develop the proceduresfurther.

In laparoscopic procedures, surgery is performed in the interior of theabdomen through a small incision; in endoscopic procedures, surgery isperformed in any hollow viscus of the body through narrow endoscopictubes inserted through small entrance wounds in the skin. Laparoscopicand endoscopic procedures generally require that any instrumentationinserted into the body be sealed, i.e., provisions must be made toensure that gases do not enter or exit the body through the laparoscopicor endoscopic incision as, for example, in surgical procedures in whichthe surgical region is insufflated. Moreover, laparoscopic andendoscopic procedures often require the surgeon to act on organs,tissues and vessels far removed from the incision, thereby requiringthat any instruments be used in such procedures be long and narrow whilebeing functionally controllable from one end of the instrument, i.e. theproximal end.

In hernia surgery, as compared to gall bladder surgery, certainprocedures and instruments are the same, yet certain of the instrumentrequirements differ. For example, in hernia surgery a suitable meshmaterial is generally sutured over the opening in the tissue. The meshmaterial is often also attached by sutures and left within the openingto act as a reinforcing agent for tissue regrowth in the area of thesurgery. One example of a mesh material currently utilized in herniasurgery includes a polypropylene material marketed by the Ethicondivision of Johnson & Johnson, New Brunswick, N.J., under the trademarkMARLEX. Another example of a mesh material is a tri-fluoroethylenematerial marketed by W.L. Gore & Associates, Newark, Del., under thetrademark GORE-TEX.

As noted, during conventional invasive surgical procedures, such meshmaterials are often sutured within the surgical opening or over thesutured opening by conventional suturing techniques. However, with theadvent of laparoscopic surgery the need for suitable mesh attachmenttechniques through the relatively narrow endoscopic tubes or cannulas isclearly defined. Up to the present, such devices or staples suitable formesh attachment have not yet been developed.

U.S. Pat. No. 4,944,443 to Oddsen et al. discloses an instrument andmethod for applying and forming staples into body tissue to suture ahernial opening. The staple is applied to two pieces of body tissue onopposite sides of the opening which are gripped, approximated and heldtogether by a tissue positioning assembly. U.S. Pat. No. 4,919,152 toGer relates to a surgical instrument for placing a single clip which isproposed for use in direct hernia repair for closing sacs having narrowneck openings.

Up to the present there remains a need for an apparatus which isparticularly adapted to endoscopically apply staples for attachingobjects such as surgical mesh to body tissue in a manner to positivelysecure the object to the body tissue without danger of separationthereof after the attachment is completed. The present invention relatesto such an apparatus as well as a method for attaching such objects withstaples particularly configured and adapted to accomplish theseobjectives.

SUMMARY OF THE INVENTION

An apparatus for endoscopic application of a surgical staple adapted toattach objects to body tissue, which comprises frame means, generallyelongated endoscopic means connected to the frame means and extendingdistally therefrom, means for storing at least one surgical staple atthe distal end portion, the staple configured and adapted to attach anobject to body tissue, means for individually advancing the at least onestaple distally for positioning adjacent the body tissue, and anvilmeans for closing the staple in a manner to encompass at least a portionof the object and to penetrate the body tissue to attach the portion ofthe object to the body tissue. Preferably, the apparatus for endoscopicapplication of surgical staples is adapted to attach surgical mesh tobody tissue and comprises means for storing a plurality of surgicalstaples in generally stacked relation to permit configuring anddimensioning the endoscopic means for insertion into an endoscopiccannula tube. The staples are configured and adapted to attach thesurgical mesh to body tissue, particularly for hernia related surgery.Further, the staple advancing system extends from the frame means to theendoscopic means and is activated by a trigger mechanism pivotallyattached to the frame means and forming a part thereof.

The surgical staples are stored in stacked relation at the distal end ofthe endoscopic means. Also, the endoscopic means defines a longitudinalaxis and the surgical staples are stacked to form an angle with thelongitudinal axis, thereby improving visibility.

The surgical staple storing means is pivotally attached at the distalend portion of the endoscopic means wherein the surgical staple storingmeans is selectively pivotable by the user. Pivotal control means islocated at the proximal end of the endoscopic section to pivot thesurgical staple storing means from a proximal location. The location ofthe pivotal control means is provided for convenience and accessibilityto the operator. The pivotal control means of the staple storing meanscomprises a member movable with respect to the endoscopic means inproximal and distal directions and adapted to position said surgicalstaple storing means at substantially zero degrees with respect to saidlongitudinal axis when said pivotal control means is in a first positionand said surgical staple storing means forms an angle of up to about 45degrees when said pivotal control means is in a second position.

The first position may be the proximalmost position of the pivotalcontrol means and the second position may be the distalmost positioncorresponding to the staple storing means being pivoted up to about 45degrees with respect to at least one side of the longitudinal axis.Further, the pivotal control means of the staple storing means mayinclude a generally cylindrical movable member slidably positioned abouta proximal portion of the endoscopic means.

The staple storing means may also comprise a rotatable sleeve positionedwithin the movable member and adapted to rotate in a first directionwhen the movable member is moved toward the proximalmost position and torotate in the opposite direction when the movable member is moved towardthe distalmost position.

The surface at the distalmost end portion of the rotatable sleeve mayform an angle with respect to the longitudinal axis of the endoscopicmeans and the distalmost end surface of the rotatable sleeve may bepositioned and arranged to engage elongated control means positionedwithin the endoscopic means for engagement with at least a portion ofthe staple storing means at a distal location of the endoscopic meanswhereby rotatable movement of said rotatable sleeve correspondinglyproduces longitudinal movement of said elongated control means.Preferably, the elongated control means comprises at least two elongatedrods positioned within the endoscopic means and in engagement with thedistalmost end portion of the rotatable sleeve at the proximal endsthereof and arranged to engage at least a portion of the staple storingmeans at respectively opposed locations such that rotation of therotatable sleeve in a first direction produces distal movement of atleast one of the rods and corresponding proximal movement of the otherrod and rotation of the rotatable sleeve in the opposite directionrespectively produces correspondingly respectively opposite movement ofthe rods.

The staple storing means includes an indentation adapted to receive eachrod in engagement therewith and each rod is correspondingly configuredat the distal end to engage the respective indentation to produce smoothrotation of the staple storing means when the rods are respectivelymoved distally and proximally. Further, the means for individuallyadvancing the staples distally is user controllable at a proximallocation. The means for individually advancing said staples distallycomprises a plate member positioned adjacent and proximal of thelowermost staple and adapted to be movable distally whereby the platemember engages the lowermost staple and advances the staple in thedistal direction. Also, the means to individually advance the staplescomprises staple pusher means which comprises said plate member and theplate member is dimensioned, configured and arranged to engage andadvance each staple distally.

The staple pusher means includes an elongated member of super elasticmaterial such as NITINOL brand metal and is adapted to advance thestaples and transmit closing force thereto. This member is furtheradapted to resiliently deform to facilitate pivoting movement to thestaple storing means. The staple pusher means further comprises anelongated staple firing rod.

In the preferred apparatus the staple pusher means is biased to apre-fired position by a constant force negator spring which prevents theoperator tendency to rotate the hand, which occurs when a spring forceincreases.

Also a trigger mechanism is pivotally mounted for pivotal movementagainst the force of the negator spring when pivoted proximally to aposition corresponding to advancing the pusher means distally to advancethe staple next in line for closure.

The staple storing means includes anvil means positioned distally of thestack of staples and configured, dimensioned and adapted to be engagedby each said staple when said staple is advanced distally by said platemember.

The staples are each formed of a first length of wire having at leasttwo leg portions at each end extending generally perpendicular to saidfirst length of wire. The anvil means comprises at least two upstandingleg members positioned to be engaged by the first length of wire of eachstaple when the staple is advanced distally by the plate member. The legmembers of the anvil means are dimensioned, positioned and arranged suchthat engagement by the first length of wire of each staple causes theleg members of the staple to fold inwardly toward the first wire due tothe configuration of the staple and the corresponding configuration ofthe distalmost staple engaging edge of the plate member. The platemember is connected to elongated means comprised of super elastic memberand the firing rod.

The means to move the elongated means and the plate member in distal andproximal directions is positioned within the frame means. Resilientmeans is positioned below each staple such that upon completion ofclosure thereof, and withdrawal of the staple advancing plate member theresilient means resiliently lifts the staple above the level of theanvil means. Also, the elongated means extends from the frame meansthrough the endoscopic means whereby a distal portion thereof and theplate member are positioned within the staple storing means. The meansto advance the elongated means and the plate member includes ratchet andassociated pawl means adapted to prevent proximal movement thereofexcept when the staple advancing means is advanced to the distalmostposition whereby the pawl means is released so as to permit return ofthe elongated member and the staple advancing plate member to theproximalmost position to advance the next staple of the stack ofstaples.

Preferably, the ratchet and pawl means comprises a ratchet memberfixedly connected to the frame means and has a ribbed surface, and pawlmeans connected to the elongated plate advancing means and positionedadjacent the ratchet member and adapted to engage the ribbed surface.The ribbed surface is correspondingly configured and dimensioned toprevent proximal movement of the pawl means when the elongated plateadvancing means is advanced at least partially in the distal direction.The ribbed surface of the ratchet member is comprised of a plurality ofsubstantially and successive V-shaped peaks and valleys and the pawlmeans is configured at one end portion to engage the peaks and valleysin a manner which permits distal slidable movement thereof but preventsproximal movement thereof. Also, means is provided to release the pawlmeans when the pawl means is in the distalmost position corresponding tothe distalmost position of the plate member and closure of the staplehas been completed. A finger operative lever is adapted to producedistal movement of the elongated member and the plate member when saidlever is pivotally moved.

The frame means has a pistol-like shape and includes a first memberhaving a distal end connected to the endoscopic means and a manuallygripping member at the proximal end is adapted to be gripped manually bythe user. The endoscopic means is rotatable about the longitudinal axisand the pivotal control sleeve of the staple storing means is connectedfor rotation with the endoscopic means such that rotation thereofproduces corresponding rotation of said endoscopic means. As describedhereinabove, distal and proximal movement thereof produces pivotalmovement of the staple storing means. The staple storing means isadapted to be pivoted up to about 45 degrees with respect to each sideof the longitudinal axis whereby full pivotal articulation thereof isprovided of about 90 degrees.

A surgical staple is adapted to attach objects such as mesh materials tobody tissue which comprises, a length of wire having a central portion,a wire leg member extending generally perpendicular to the central wireportion at each end portion and adapted to penetrate the object and bodytissue when positioned in adjacent engaged relation therewith andadvanced thereinto. A bridge portion connects the central wire portionto each leg member and has a first generally arcuate portion generallyconcave and facing in a direction generally toward the center of thecentral wire portion. The inwardly facing concave portions are connectedto each leg member by an arcuate portion having a generally concaveconfiguration in the opposite direction so as to respectively engagablysupport each bridge portion against a pair of anvil members wherebyapplying force to the bridge portions causes the leg members to bendinwardly toward the central wire portion at respective locations inwardof the first mentioned arcuate portions in a manner to form an acuteangle relative thereto. The maximum distance between the central wireportion and each folded leg member is sufficient to grip the object andto penetrate the body tissue sufficient to attach the object to the bodytissue. Each said leg member has a pointed tip to penetrate the objectand the body tissue.

Each leg member of the staple has a tapered portion at the free end. Thetapered portion on one leg member is located opposite the taperedportion on the other leg member whereby folding the leg members inwardlytoward each other causes each tapered portion to respectively cam theother leg member whereby the leg members are folded toward each other inadjacent relation without interference with each other. The central wireportion is positioned inwardly of each bridge portion to facilitategripping the object between the central wire portion and the legmembers. Further, each leg member has a generally arcuate shape and hasa concave portion thereof generally facing the other leg member. Thesurgical staple is preferably made of titanium. Also, the central wireportion includes a portion thereof which is positioned inwardly of thebridge portions in the body tissue gripping direction to thereby form abight portion for gripping the object and body tissue in combinationwith the leg members.

A method is disclosed for endoscopically applying surgical staples toattach objects such as surgical mesh to body tissue comprising the stepsof storing at least one surgical staple in endoscopic means havingstoring means positioned at the distal end portion and adapted foradvancing and closing said staple, positioning the object adjacent thebody tissue for attachment to the body tissue, and advancing thesurgical staple distally so as to penetrate the object and the bodytissue and to close the staple in a manner to attach the portion of theobject to the body tissue. Preferably, a plurality of surgical staplesare stored in stacked relation in the endoscopic means.

The invention relates to the combination of a cannula adapted forinsertion into a body cavity, the cannula including valve means forsealing the cannula. An endoscopic surgical staple applier has a frame,and an endoscopic portion defining a longitudinal axis, and extendingdistally from the frame, the endoscopic portion configured and adaptedfor insertion into the cannula through the valve means in sealingengagement therewith. The endoscopic portion further includes aplurality of surgical staples in stacked relation, and means forindividually pushing the staples through the distal end thereof isprovided whereby staple closing means causes the staples to be closedwhile attaching an object such as surgical mesh to the body tissue. Sealmeans is positioned and adapted to obstruct passage of gaseous mediafrom the body cavity.

A kit is also disclosed for endoscopic application of a surgical stapleadapted to attach surgical mesh to body tissue in hernia repair, whichcomprises, surgical mesh, cannula means, and apparatus for endoscopicapplication of a surgical staple adapted to attach the surgical mesh tobody tissue. The apparatus and staples of the kit are constructedaccording to the invention. The components may be supplied as part of akit or they may be packaged in a blister-type or other package.

In an alternative embodiment, an apparatus is disclosed for endoscopicapplication of a surgical staple adapted to attach an object to bodytissue, which comprises frame means, generally elongated endoscopicmeans connected to the frame means and extending distally therefrom,cartridge means for storing at least one surgical staple at the distalend portion, the staple being configured and adapted to attach an objectto body tissue. Means is provided for individually advancing the atleast one staple distally for positioning adjacent the body tissue, andanvil means is provided for closing the staple in a manner to encompassat least a portion of the object and to penetrate the body tissue toattach the portion of the object to the body tissue.

In the preferred embodiment, the apparatus includes on the elongatedendoscopic means, means for engagably receiving and supporting thecartridge in a manner to advance the staples individually for endoscopicapplication.

A cartridge is also disclosed for containing a plurality of surgicalstaples for fastening body tissue which comprises housing means adaptedto support the plurality of surgical staples, and means dimensioned,positioned and adapted to engage each staple as the staple is advancedfrom the housing means in a manner to prevent the staple from deformingout of the plane of the staple when the staple is deformed to attach thestaple to body tissue.

The invention also relates to a system for attaching surgical mesh tobody tissue adjacent a tissue repair within a body cavity whichcomprises, a frame, and an elongated endoscopic section connected at theproximal end thereof to the frame and extending distally therefrom, theendoscopic section configured and adapted for insertion into anendoscopic cannula within the body cavity. The endoscopic sectionincludes a disposable cartridge adapted to store a plurality of surgicalstaples in stacked relation, the cartridge being removably engagablysupported by a pivotal support member, each staple being formed of afirst length of wire having at least one leg portion at each endextending generally perpendicular to said first length of wire, the legportions being continuous with said first length of wire and configuredto facilitate insertion into surgical mesh and adjacent body tissuetherebeneath when said staple is advanced toward said mesh, the staplefurther being configured to facilitate folding said legs inwardly towardsaid first length of wire when at least a portion of the first length ofwire is supported against anvil means, whereby said leg portions andsaid first length of wire grip said mesh and the body tissuetherebetween to attach at least the gripped portion of the mesh to thebody tissue. Means is provided for individually advancing the staplesdistally for positioning adjacent the mesh and the body tissue. Means isalso included for providing perceptible tactile indicator when eachstaple is advanced to a predetermined position. Means is provided forclosing each said staple while said staple is advanced toward said meshand the body tissue so as to penetrate said mesh and the body tissuewhile causing said leg members to fold inwardly toward said first wireof said staple to grip said mesh and the body tissue between said firstwire and said legs.

A method is disclosed for endoscopically applying surgical staples toattach objects such as surgical mesh to body tissue comprising the stepsof storing at least one surgical staple cartridge positioned at thedistal end portion and adapted for advancing and closing the staple,positioning the object adjacent the body tissue for attachment to thebody tissue, and advancing the surgical staple distally so as topenetrate the object and the body tissue and to close the staple atleast sufficient to attach said portion of the object to the bodytissue.

A kit is disclosed for endoscopic application of a surgical stapleadapted to attach surgical mesh to body tissue in hernia repair, whichcomprises surgical mesh, cannula means, and apparatus for endoscopicapplication of a surgical staple adapted to attach the surgical mesh tobody tissue. The apparatus includes frame means, and generally elongatedendoscopic means connected to said frame means and extending distallytherefrom and dimensioned and configured for insertion into the cannulameans. The endoscopic means includes a removable and replaceablecartridge for storing a plurality of surgical staples at the distal endportion, the staple configured and adapted to attach objects to bodytissue, means for individually advancing the at least one stapledistally for positioning adjacent the surgical mesh and the body tissue,and anvil means for closing the staple at least sufficient to encompassat least a portion of said surgical mesh and to penetrate said surgicalmesh and the body tissue in a manner to attach the portion of thesurgical mesh to the body tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention are described hereinbelow withreference to the drawings wherein:

FIG. 1 is a perspective view from above, of an apparatus constructedaccording to the present invention for applying surgical staples toattach objects to body tissue;

FIG. 1A is a perspective view of the distal end portion of the apparatusof FIG. 1 illustrating an alternative embodiment for pivoting the staplestorage magazine;

FIG. 2 is an exploded perspective view with parts separated, of thehandle of the instrument of the invention and the associated components;

FIG. 3 is a cross-sectional view taken along lines 3-3 of FIG. 1,illustrating the handle mechanism of the instrument in the pre-firedcondition;

FIG. 4 is a cross-sectional view taken along lines 4-4 of FIG. 3illustrating the mechanism at the proximal end of the instrument forproviding controlled distal movement to advance and to close staples atthe distal end;

FIG. 5 is an enlarged cross-sectional view of the pawl and ratchetsystem in the handle which prevents proximal movement of the stapleadvancing system after distal movement has begun;

FIG. 6 is a view similar to FIG. 5 illustrating the pawl and ratchetsystem of FIG. 5 after a staple has been fired and during the proximalmovement of the firing mechanism;

FIG. 7 is a cross-sectional view similar to FIG. 3 with the stapleadvancing actuating handle in the full proximal pivoted positioncorresponding to firing of a staple;

FIG. 8 is an enlarged cross-sectional view taken along lines 8-8 of FIG.1 illustrating the rotating mechanism for the endoscopic portion and thesystem for pivoting the staple storage magazine from the proximal end;

FIG. 9 is a cross-sectional view taken along lines 9-9 of FIG. 8;

FIG. 10 is a cross-sectional view taken along lines 10-10 of FIG. 8illustrating the system for providing pivotal motion of the staplestorage magazine located at the distal end;

FIG. 11 is a cross-sectional view taken along lines 11-11 of FIG. 9illustrating further details of the system for providing pivotal motionto the staple magazine at the distal end;

FIG. 12 is a view of the interior surface of the inner sleeve of themanually operable collar of FIGS. 8-11, projected as a flat surface toillustrate the helical groove provided for coaction with a pin toprovide pivotal motion for the staple magazine at the distal end;

FIG. 13 is a perspective view of an internal sleeve and pin which coactswith the inner sleeve shown in FIGS. 11 and 12 which forms part of thesystem for pivoting the staple magazine at the distal end;

FIG. 14 is an exploded perspective view with parts separated, of theendoscopic section of the instrument of the invention, illustrating thestaple advancing system and components thereof;

FIG. 15 is an exploded perspective view with parts separated, of thestaple storage magazine which is controllably pivotally mounted at thedistal end portion of the endoscopic section;

FIG. 16 is a cross-sectional view taken along lines 16-16 of FIG. 1illustrating the distal end of the instrument including the pivotalstaple magazine at three positions;

FIG. 17 is a cross-sectional view taken along lines 17-17 of FIG. 16illustrating the staple next in line and the pusher plate provided foradvancing the staple toward a staple closing anvil;

FIG. 18 is a cross-sectional view of the distal end of the instrumentshown in engagement with a surgical mesh positioned against body tissueprior to firing the staple;

FIG. 19 is a cross-sectional view taken along lines 19-19 of FIG. 18;

FIG. 20 is a cross-sectional view similar to FIG. 18 during the firingof the staple and after penetration into the mesh and body tissue, butprior to closure;

FIG. 21 is a view similar to FIG. 19, taken along lines 21-21 of FIG.20;

FIG. 22 is a cross-sectional view of the distal end of the instrument ofthe invention after closure of the staple in position to attach thesurgical mesh to the body tissue;

FIG. 23 is a cross-sectional view taken along lines 23-23 of FIG. 22illustrating the staple ejection system for releasing the closed staplefrom the anvils after firing;

FIG. 24 is a cross-sectional view similar to FIG. 22 illustrating thestaple after closure about the surgical mesh and body tissue and thedistal end of the instrument withdrawn from the surgical mesh;

FIG. 25 is a cross-sectional view taken along lines 25-25 of FIG. 24;

FIG. 26 is a cross-sectional view of the distal end portion of thestaple storing magazine of the instrument after firing a staple;

FIG. 27 is a frontal view of a repair in body tissue illustrating oneexample of an arrangement of staples of the invention for attachment ofreinforcing surgical mesh to the tissue;

FIG. 28 is a perspective view of a staple constructed according to theinvention for attaching surgical reinforcing mesh to body tissue over asurgical repair;

FIG. 29 is another example of arranging the staples for attachment ofthe reinforcing surgical mesh to the body tissue in the area of a herniarepair;

FIG. 30 is a perspective view from above similar to FIG. 1, of analternative embodiment of the present invention which includes areplaceable staple storing cartridge at the distal portion of theendoscopic section;

FIG. 31 is an exploded perspective view with parts separated, of thehandle of the instrument of FIG. 30 illustrating a feature whichprovides perceptible tactile sensing of the pre-positioning of eachstaple prior to closing the staple with respect to the body tissue;

FIG. 32 is an exploded perspective view with parts separated, of thesystem at the distal end portion of the endoscopic section for pivotallysupporting a replaceable staple storage cartridge;

FIG. 32A is an exploded perspective view of the staple storage cartridgewith parts separated;

FIG. 32B is a view taken along lines 32B-32B of FIG. 32A, illustratingthe “L” shaped staple holders on the bottom of the cartridge housing;

FIG. 33 is a side elevational view of the distal portion of theendoscopic section illustrating the staple storage cartridge supportmember and the staple storage cartridge in position for insertion ontothe support member;

FIG. 34 is a plan view from above of the staple storage cartridge andrelated pivotal support member illustrating the feature of the inventionwhich prevents each staple from rolling backwardly as they are deformed;

FIG. 35 is a cross-sectional view of the staple storage cartridge andrelated pivotal support member taken along lines 35-35 of FIG. 30;

FIG. 36 is a cross-sectional view taken along lines 36-36 of FIG. 35illustrating the initial position of the staple indicator when thecartridge is loaded with a full complement of staples;

FIG. 37 is a cross-sectional view taken along lines 37-37 of FIG. 35illustrating the staples stacked within the cartridge;

FIG. 38 is a cross-sectional view of the staple storage cartridge andrelated support member after the last staple has been fired;

FIG. 39 is a partial internal view of the handle portion and the staplestorage cartridge illustrating the perceptible tactile staplepre-positioning feature of the invention;

FIG. 40 is a perspective view of the internal sleeve and pin which formspart of the pivoting system for the staple storage cartridge, similar tothe sleeve disclosed in FIG. 13 in connection with the previousembodiment of the invention; and

FIG. 41 is a cross-sectional view taken along lines 41-41 of FIG. 30,illustrating schematically gaseous seal means for the endoscopicsection.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS GENERAL

In general, the objective of the apparatus is to store a plurality ofstaples in the magazine as will be described in greater detail, and toindividually advance each staple distally for closure about anvils whileattaching a surgical mesh to the body tissue.

Following a general description of the present instrument, thedescription will be divided into separate sections to describe thestructure and the desired movements produced thereby. Those sectionsinclude the handle section, the staple storage magazine pivoting system,the endoscopic section and staple firing system, the staple storagemagazine, the staple closing system and the inventive staple. Also a kitfor attaching objects such as surgical mesh is described.

The Instrument

Referring initially to FIG. 1 there is illustrated in perspective viewthe apparatus 10 particularly adapted for endoscopic application ofsurgical staples to attach surgical mesh to body tissue during herniarepair. Except where noted otherwise, the materials utilized in thecomponents of the apparatus generally include such materials aspolycarbonate for housing sections and related components, and stainlesssteel for such components which transmit forces. One preferredpolycarbonate material is LEXAN brand polycarbonate available fromGeneral Electric Company. Other specific preferred materials such asnylon or glass filled nylon (for strength) are also utilized. However,equivalent alternative materials will readily come to the mind of thoseskilled in the art.

The apparatus 10 includes handle portion 12, and endoscopic section 14having at the distal end portion a staple storage magazine 16 whichpivots with respect to at least one side of the longitudinal axisextending centrally through the endoscopic section as shown in FIG. 1.Generally, staple storage magazine 16 will selectively pivot up to about45 degrees with respect to the aforesaid longitudinal axis. In theillustration of FIG. 1 the staple storage magazine 16 is shown ingeneral alignment with the longitudinal axis of the endoscopic sectionand in phantom to illustrate a range of movement. The total range ofpivotal motion of the staple storage magazine 16 as shown isapproximately 90 degrees, i.e. 45 degrees to each side of neutral.

Referring generally to FIG. 1, the handle 12 of instrument 10 includesmanual grip 18 and pivotal trigger 20 which is pivoted toward and awayfrom manual grip 18. Trigger 20 is pivoted toward manual grip 18 duringthe staple advancing and firing sequence which will be described infurther detail. Trigger 20 pivots away from manual grip 18 to return theinstrument to the pre-fired condition in position for firing the staplenext in line.

A double knurled finger operative collar 22 is rotatable and adapted torotate the entire endoscopic section 14 a full 360 degrees as will bedescribed hereinbelow, while proximal movement of the finger ring 22produces pivotal motion of the staple storage magazine to one of thepositions shown in phantom in FIG. 1. To achieve the other positionshown in phantom in that Fig., the collar 22 may be simply rotated 180degrees thereby rotating the entire endoscopic section and causing theposition of the magazine 16 to be reversed as shown to the otherposition shown in phantom. Thus, it can be seen that the combination offull rotation of the endoscopic section and the pivotal movement of thestaple storing magazine facilitates a wide range of articulation of thedistal end of the staple magazine 16, thus facilitating application ofstaples over a wide range of locations (±180 degrees) and in any of aplurality of orientations. In the embodiment of the invention shown inthe Figs., when the collar 22 is moved to its proximalmost position thestaple magazine is in one of the positions shown in phantom in FIG. 1,i.e. at an angle with respect to the longitudinal axis of theinstrument. When the collar 22 is advanced to the distalmost positionthe staple magazine assumes the position shown in FIG. 1, i.e. inalignment with the longitudinal axis of the instrument.

Thus, in the preferred embodiment of FIG. 1, it can be seen that thefull 90 degrees of movement of the magazine may be achieved simply bylongitudinal movement of collar 22 in combination with full rotation ofthe endoscopic section. The longitudinal movement of collar 22 causespivotal movement of the staple storing magazine to 45 degrees in onedirection and rotation of the endoscopic section provides completion ofthe articulation of the magazine. Both of these movements incombination, facilitate a wide range of maneuverability of the distalend of the staple magazine 16, thus facilitating application of staplesover a wide range of locations (±180 degrees) and in any of a pluralityof orientations.

Alternatively, the positions of the staple storing magazine 16 may beachieved as shown in FIG. 1A, i.e. by movement of the magazine betweenzero degrees and about 45 degrees on either side of the longitudinalaxis. In such arrangement, to achieve the positions shown in phantom inFIG. 1A, the collar 22 is moved distally and proximally, equal distanceson either side of a neutral detent. Movement in one direction wouldpivot the magazine to one side and movement in the other direction wouldcause pivotal movement of the magazine in the opposite direction. Thedirections selected would be arbitrary. However, in this last describedembodiment the orientation of the magazine would be the same throughoutthe 90 degree pivoting range, whereas in the preferred embodiment ofFIG. 1, the orientation of the magazine when on one side is opposite theorientation when on the other. Further, in this embodiment theendoscopic section will be somewhat longer to accommodate the additionalmovement of collar 22.

The Handle Section

Referring to FIG. 2, there is shown an exploded perspective view withparts separated, of the handle of the instrument with associatedcomponents. The handle is comprised of an outer housing preferablyformed of separate sections as shown, of polycarbonate material. Theseparate parts shown are attached by welding, adhesives, etc. FIG. 3illustrates a cross-sectional view of the handle mechanism taken alonglines 3-3 of FIG. 1. The ultimate purpose of the handle mechanism is toprovide controlled distal movement to the pusher assembly 24, a portionof which is shown in FIG. 2. The pusher assembly extends through theendoscopic section 14, a portion of which is shown in phantom in FIG. 2.In the embodiment shown, the endoscopic section shown is intended to bepermanently and rotatably attached to the instrument via rim 16 a formedon bushing 16 and rim 15 a on half round sleeve 15. The instrument shownis contemplated to be entirely disposable. Half round sleeve 15 isintegrally formed with barrel 17 which is in turn affixed to handle 12at the nose piece 13.

However, it is also contemplated and within the scope of the inventionto construct the endoscopic section to be selectively detachable wherebythe handle may be sterilized and reused, or the endoscopic section canbe sterilized, and the staple storage magazine re-loaded with staplesfor re-use. Alternatively a replacement staple magazine, and optionallya replacement endoscopic section, may be detachably secured to adisposable handle for multiple use during a single surgical procedure.Thus, any combination of alternatives may be incorporated within thescope of the invention.

Referring now to FIG. 2 in conjunction with FIGS. 3, 7 and 14, pusherassembly 24 includes flanged thrust bar 26 connected to firing rod 28 bylost motion connector 30 as shown in FIG. 3. Lost motion connector 30 isa bar having a generally “U-shaped” configuration as shown. The lostmotion connector 30 provides a positive connection between flangedthrust bar 26 and firing rod 28, yet provides a small space between thefiring rod and the thrust bar 26 as will be described. Since therespective slots 28 a and 26 a in the firing rod 28 and in the thrustbar 26 are dimensioned slightly larger in width than the thickness ofthe legs 30 b and 30 c of the lost motion connector 30 which arereceived in these slots, a small degree of relative movement (i.e.,about one tenth ( 1/10) of an inch) is provided permitted between thecomponents in the staple firing chain. This small degree of movement isprovided for several reasons as follows: 1) minor pivotal proximalmovements of the trigger mechanism will not immediately result inengagement between the pusher assembly and the staple next in line, thusavoiding inadvertent distal movement of the staple during handling byoperating room personnel, or positioning by the user; 2) engagement ofthe pusher assembly with the next staple will not occur until the pawland ratchet plate of the clutch mechanism (described hereinbelow) takesplace, thus preventing inadvertent partial advancement of severalstaples at a time. This would occur if the operator were allowed topartially activate the trigger mechanism several times over the samepart of its cycle. The clutch mechanism prevents such movements.Further, this free movement of the thrust bar 26 also permits the stapleadvancing and forming components to engage each other smoothly withoutjamming or intercomponent interference with themselves and with thecomponents of the system for pivoting the staple storage magazine 16 aswill be described hereinbelow. Explanation of the pivoting system forthe staple storage magazine will illustrate the advantages of the lostmotion connector bar in further detail.

Trigger mechanism 20 is pivotally attached at pivot pin 32 for pivotalmovement toward and away from handle grip 18, and is adapted to produceupward and downward rotational movement of triangular member 34 whenhorizontal pin 36, attached to trigger mechanism 20, traverses an upwardarc whose center of rotation is located at pivot pin 32. Thus, it can beseen that when handle grip 18 is positioned in the palm of the user'shand and trigger mechanism 20 is squeezed toward handle grip 18,horizontal pin 36 traverses an upward arc while engaging the longer side34 a of triangular member 34 as shown. This movement causes triangularmember 34 to rotate upward in a counterclockwise direction while uprightmember 35 to which it is attached, pivots forwardly about a point ofrotation defined by pivot pin 37 located at the lowermost end of ahandle grip 18 shown in FIG. 2.

As can be seen in FIGS. 2 and 3, pusher assembly 24 is connected toupright member 35 through aperture 33 such that inward squeezing oftrigger mechanism 20 will cause the entire pusher assembly to advancedistally against the constant force provided by negator spring 40 asshown. The negator spring 40 is formed of a resilient flat springmaterial coiled about the rotational bar 42 which is rotationallymounted about cross member 44 which forms part of bracket 46. The freeend of negator spring 40 is attached to an anchor pin 48 via aperture 49as shown, while the spring 40 is normally biased toward the coiledconfiguration as shown in FIG. 3. It can therefore be appreciated thatafter squeezing trigger mechanism 20 the full stroke from the positionshown in FIG. 3 toward handle grip 18 to the position shown in FIG. 7,release of the trigger mechanism will permit the negator spring 40 toassume control and to return rotational bar 42 to the pre-fired proximallocation by the automatic winding action of the negator spring 40 to itsoriginal unloaded configuration. This motion in turn causes the entirepusher assembly 24 to return to the proximalmost pre-fired position asshown in FIG. 3. The constant force of negator spring 40 uniquelyprevents the natural tendency of the user to rotate the hand as withsprings which increase in force when progressing through a full springcycle.

Referring once again to FIGS. 2 and 3, trigger stop device 50 isattached to trigger mechanism 20 and is configured and dimensioned forengagement with handle grip 18 in a manner to thereby limit the proximalpivotal movement of trigger mechanism 20. Depending upon the particularlimits required in the apparatus, trigger stop device 50 can bedimensioned accordingly.

Referring now to FIGS. 4-6, the structure and function of the uni-motionclutch mechanism will be described. This clutch mechanism preventsproximal movement of the pusher assembly in the event the triggermechanism is released after the squeezing motion of the triggermechanism and the advancement of the pusher assembly has begun butbefore the full stroke is completed. The clutch mechanism isself-releasing when the pusher assembly reaches the distalmost position,thus permitting the entire pusher assembly to return to the pre-fired,or proximalmost condition, and the trigger mechanism to also return tothe pre-fired position.

Referring now to FIG. 4 in conjunction with FIGS. 5 and 6, ratchet plate52 is fixed to barrel 17 and therefore fixed with respect to the handlehousing and possesses a surface defined by a plurality of right angletriangular shaped parallel ridges 56 as shown in FIGS. 4-6. Pawl 58 isrockably mounted for distal and proximal movement with pusher assembly24 through barrel 17, and is biased toward ratchet plate 52 by resilientwire spring 60 as shown. The location of pawl 58 shown in FIG. 4corresponds to the pre-fired condition of the apparatus with negatorspring 40 in the fully wound position and pawl 58 located proximal ofratchet plate 52. Further, pawl 58 is preferably of stainless steelwhile ratchet plate 52 is made of brass or other compatible material.

While trigger mechanism 20 is squeezed toward handle grip 18 producingdistal motion of the entire pusher assembly 24, pawl 58 engagably slidesdistally past the ratchet surface 56 of ratchet plate 52 as shown inFIG. 5 such that one corner of the tip 62 of the pawl 58 sequentiallyengages each right angled ridge of ratchet plate 52 to thereby preventproximal movement of the pusher assembly in the event the triggermechanism is released by the operator. The engagement of pawl 58 withratchet plate 52 provides audible confirmation that the pusher assemblyis moving distally since the user will hear a series of progressiveaudible clicks. This action—which is best shown in FIG. 5—continues withthe tip 62 of pawl 58 sliding past the ratchet surface of the ratchetplate 52 until the pawl is positioned distally of the distalmost tooth.

After completion of the staple firing stroke and upon release of thetrigger mechanism 20 the pawl 58 moves proximally with the pusherassembly as described under the action of spring 40. The end portion 62of pawl 58 which is now free, engages the distal end of the ratchetplate 52 causing the pawl to rock to the reverse direction shown in FIG.6 so as to slide proximally past the ratchet surface of ratchet plate 52without interference to the proximal movement of the pusher assembly 24.Thus, it can be seen that the clutch mechanism as described willeffectively permit squeezing the trigger mechanism 20 toward the handlegrip 18 while maintaining all positions midway through the stroke in theevent the operator releases the grip, while permitting return motionthereof after the stroke has been completed. The clutch mechanism alsoallows the operator to advantageously preposition a staple such that thelegs of the staple protrude from the distal end of the staple magazinediscussed hereinafter, and then to release pressure from the triggermechanism. The operator may then turn full attention to locating theprepositioned staple in the desired target location, at which point thepivoting of the trigger mechanism may be resumed and the cyclecompleted. This staple prepositioning greatly facilitates stapleplacement.

The Staple Storage Magazine Pivoting System

Referring to FIGS. 8-14, the system for pivoting the staple storagemagazine located at the distal end of the endoscopic section 14 will nowbe described. FIG. 8 illustrates double knurled finger operable collar60 which is mounted for rotation with the endoscopic section 14 byinwardly extending pin 62 which is slidably positioned withinlongitudinal groove 64 in the outer housing half section 14 a ofendoscopic section 14, as shown in further detail in FIG. 14. Thuscollar 60 is readily slidable distally and proximally while pin 62slides within groove 64. Thus while permitting slidable movement ofcollar 60, pin 62 prevents independent rotation of collar 60 relative tothe endoscopic section 14. Accordingly, when collar 60 is grippedbetween the user's fingers and rotated, the endoscopic section 14rotates with the collar.

Positioned within finger operable collar 60 is helically grooved innersleeve 66 fabricated of a suitable plastic material such as nylon, glassfilled for strength. Helically grooved inner sleeve 66 is generallycylindrical in shape and includes a helical groove 68 shown in phantomlines in FIG. 8 and illustrated schematically in the projected frontalview of the sleeve shown in FIG. 12. The sleeve 66 is fixedly attachedto outer collar 60 for rotation therewith. In the projected view of FIG.12, the helical groove appears as a diagonal groove having a linearshape. In FIG. 11, finger operable collar 60 is shown in cross-sectionand the inner helically grooved sleeve 66 is shown whereby helicalgroove 68 is represented at two locations as viewed in FIG. 11. In FIG.11, the cross-section of groove 68 at the 10 o'clock position (wherelines 11-11 are located in FIG. 9) is just distal of the cross-sectionof groove 68 shown in phantom at the 12 o'clock position.

Referring now to FIG. 8 in conjunction with FIGS. 9-13, elongatedinternal cylindrical sleeve 70 is positioned partially within innerhelically grooved sleeve 66 and collar 60 when collar 60 is in thedistalmost position, as shown in FIG. 8; however, when collar 60 iswithdrawn to the proximalmost position as shown in phantom lines in FIG.8, the major portion of internal cylindrical sleeve 70 is positionedwithin collar 60 as shown. Internal sleeve 70 is preferably of nylon(preferably glass filled for strength) and defines a distal face 72which is generally oriented at an acute angle with respect to thelongitudinal axis of the instrument as shown clearly in FIGS. 8 and 13.The sleeve 70 contains pin 74 extending radially outwardly from theouter surface as shown. Pin 74 is preferably of steel or it may beformed of nylon integral with sleeve 70. Pin 74 is positioned forslidable movement within the helical groove 68 of inner sleeve 66 ofcollar 60 such that proximal movement of collar 60 will cause pin 74 tofollow the groove 68 causing sleeve 70 to rotate in one direction.Similarly, distal movement of collar 60 to the position shown in phantomlines in FIG. 7 will cause pin 74 to traverse groove 68 in the oppositedirection thereby causing sleeve 70 to rotate in the opposite direction.

The significance of the rotational motion of sleeve 70 as it pertains tothe pivotal motion of staple storing magazine 16 will be described infurther detail hereinbelow. At this stage, however, it is sufficient tostate that the obliquely oriented distal face 72 of sleeve 70 engagesthe proximal ends of a pair of longitudinally extending push rods 76,78shown in phantom lines in FIG. 13 and more clearly in FIG. 14 such thatwhen collar 60 is moved distally or proximally, inner sleeve 70 alsorotates and the rods 76,78 respectively move in equal and oppositedirections by the engagement with different portions of oblique distalface 72 with these rods. In essence, one rod is engaged by a surfaceportion distal of the surface portion on the side of face 72 whichengages the other rod. Thus, when the sleeve 70 is rotated in onedirection, rod 78 moves in the distal direction while rod 76 withdrawsproximally the same distance, and when sleeve 70 is rotated in theopposite direction, rod 76 moves in the distal direction and rod 78moves proximally the same distance.

Collar 60 contains rotary ridges 60 a in the distal half andlongitudinal ridges 60 b in the proximal half, and is thus convenientlymovable longitudinally and rotatably by the user when the appropriateknurled portion is gripped between the user's fingers. However, theoperator need not grip the collar 22 at any specific locations. Theridges may be formed integral by molding procedures or alternatively maybe in the form of knurled surfaces. The rotary ridges respectivelypermit collar 60 to be finger movable distally and proximally, while thelongitudinal ridges assist in rotation of collar 60 by hand. Rotationalmotion of the collar causes the endoscopic portion 14 to rotate whileproximal movement of the collar in a preferred embodiment causes staplestoring magazine 16 to pivot up to about 45 degrees in one directionwith respect to the longitudinal axis of the instrument as shown inFIG. 1. Distal movement of the collar 60 to the distalmost positionshown in FIG. 8, causes staple storing magazine 16 to withdraw to theoriginal orientation shown in FIG. 1 which is generally in line with theendoscopic section. Thus, by pivoting the staple storing magazine up to45 degrees and by rotating the endoscopic portion 14, the total range ofmovement of the staple storing magazine is 45 degrees to either side ofthe endoscopic section traversing a total of 90 degrees of effectivepivotal movement. With respect to movements of collar 60, the directionwhich produces pivotal motion of staple storage magazine 16 away fromthe longitudinal axis or toward the axis is clearly a matter of choiceand would be determined by the respective configurations of the coactingcomponents.

In the alternative embodiment shown in FIG. 1A, the internal sleeve 70and forward face 72 are configured such that collar 22 may be positionedmidway between proximal and distal positions. The mid-position willcorrespond to the staple storage magazine being at zero degrees withrespect to the longitudinal axis. Collar movement in one direction fromneutral will produce up to 45 degrees of pivotal movement of magazine 16and collar movement in the other direction on the side of neutral willproduce pivotal movement of the magazine 16 up to 45 degrees in theother direction. A major distinction in this embodiment is that theactual orientation of the magazine with respect to the longitudinal axiswill differ on either side of neutral.

Referring now to FIGS. 15 and 16, the system for providing pivotalmotion to the staple storing magazine 16 is illustrated at the distalend of the instrument. In FIG. 16 the staple storage magazine 16 isshown in the position generally in alignment with the endoscopic sectionand is shown in phantom lines at the pivoted locations corresponding toplus or minus 45 degrees. The staple storage magazine is formed of anouter housing of a suitable plastic material such as polycarbonate andis comprised of upper housing half section 16 a and lower housing halfsection 16 b attached by welding, adhesives, etc. The upper housing halfsection 16 a contains an indentation 80 at the proximal end having a“V-shaped” cross section and the lower housing half section 16 bcontains a similar indentation 82 also having a “V-shaped” cross sectionas shown. Both indentations 80,82 are adapted to respectively engagablyreceive the distal ends of rods 76,78 (which are rounded) such that whenthe rods are respectively and alternately moved in the proximal anddistal directions as described hereinabove, one rod may advance distallyto cause the upper housing to rotate and the other rod withdraws topermit the pivotal motion of the staple magazine. For example, as shownin FIG. 16, when rod 78 moves distally, engagement of the tip of the rod78 with indentation 80 in upper housing 16 a of staple storing magazinecauses the staple magazine to pivot downwardly as shown in phantom.

Similarly, equal and oppositely withdrawing rod 76 will accommodate thedownward movement of the staple storing magazine 16. In a similarfashion when the collar 60 is moved in the opposite distal direction themovement of each rod is respectively reversed causing rod 76 to movedistally and to engage the lower housing 16 b of staple storing magazine16 and rod 78 withdraws to accommodate the pivotal movement of staplestoring magazine back to the original (or neutral) position in generalalignment with the endoscopic section as shown in FIG. 16. The lostmotion connector 30 clearly provides a minor degree of space (i.e. about1/10 inch) between the components, which space provides the advantagesmentioned previously.

Alternatively one rod may be provided and connected to the staplestorage magazine and adapted to pivot the magazine by causing such rodto move proximally and distally thereby actually pivoting the magazineabout the pivot point.

The endoscopic section 14 is shown clearly in FIG. 14 and is mounted forrotation relative to the handle section 18. As noted above, theendoscopic section may be permanently attached to handle 12 as shown ina disposable instrument; alternatively as noted above, it may beremovably attached to a re-usable handle, or a variety of othercombinations or configurations.

The Endoscopic Section

Referring again to FIG. 14 the endoscopic section is shown in explodedview with parts separated for convenience of illustration and includesupper housing half section 14 a and lower housing half section 14B. Thehousing half sections are preferably of a polycarbonate material such asLEXAN brand material mentioned previously, and are attached by welding,adhesives, etc. Positioned within the upper and lower housing halfsections is pusher assembly 24 as described in more detail below, andanvil extension 88, formed of stainless steel and having a pair ofelongated legs 90,92 which are joined at 94 at the distal end and whichcontain upwardly extending feet 88 b,88 b at the proximal end. As shownin FIG. 15, anvil extension 88 is attached at the distal end 94 to thestaple storing magazine 16 by pivot pins 89 where the staple storingmagazine is pivotally attached. The proximal connection points of anvilextension are best illustrated in FIG. 2 wherein upwardly bent feet 88a,88 b are positioned within slots 15 b in half round collar 15 which isfixedly attached to handle housing 12 by barrel 17 and nose piece 13 andrelated support members provided therein.

Anvil extension 88 is fabricated of stainless steel and its purpose isto stabilize the dimension of the endoscopic section 14 to prevent theforces acting on the components from stretching or compressing the upperand lower housing half sections 14 a, 14 b of the endoscopic sectionwhich are constructed of a polycarbonate material such as LEXAN brandmaterial. Thus, the steel anvil extension provides dimensional stabilityto the endoscopic section while the endoscopic section is supporting thecomponents being subjected to forces for supporting, advancing andforming the surgical staples as will be described.

The Staple Firing System

Referring further to FIG. 14, the steel pusher assembly 24 is formed offiring rod 28 connected to flexible elongated firing wire 102 which isin turn connected to pusher plate assembly 104 as shown. The connectionbetween firing rod 28 and firing wire 102 is a crimped or swagedconnection at 106, whereas the connection between firing wire 102 andpusher 105 is accomplished by an interference fit between the firingwire 102 and collar 108 which is attached to pusher plate 104. Firingrod 28 and pusher plate 104 are preferably made of stainless steelwhereas firing wire 102 is made to be resiliently flexible toaccommodate the pivotal movement of the staple storing magazine 16 sincefiring wire 102 is located within the instrument at the location ofstaple magazine 16. In particular, firing wire 102 is preferably made ofa super elastic metal. One example of such super elastic metal isNITINOL brand metal available from Raychem Corporation, Menlo Park,Calif. This material has a reduced tendency to fatigue after asubstantial number of cycles of deflection caused by pivoting the staplestorage magazine. Other resilient materials are also contemplated forfiring wire 102.

The Staple Storage Magazine

Referring now to FIGS. 15 through 18, there is illustrated furtherdetails of the staple storing magazine 16. As noted previously, thestaple storing magazine 16 is comprised of upper housing half 16 a andlower housing half 16 b suitably attached by welding, adhesives, etc.The magazine is adapted to contain a plurality of surgical staples 110which are particularly shaped to penetrate and to attach surgical meshto body tissue. For particular details of the shape of the staplesconstructed according to the invention, reference is made to FIG. 28.

Referring once again to FIGS. 15-18, a particular feature of the presentinvention resides in the system of storage of the staples 110 which arepositioned in adjacent stacked relation whereby the stack of staplesforms an angle with the longitudinal axis of the instrument ofapproximately 45 degrees as shown in FIG. 18. one purpose of stackingthe staples as shown is to provide greater visibility to the user by thefact that the outer surface of the upper housing half section adjacentthe stack of staples forms a similar angle and provides visibility tothe user at the distal end of the staple storage magazine. Angularstacking of the staples as shown greatly facilitates storage of aplurality of staples in a structure configured and dimensioned for usein endoscopic applications, e.g., for use through a trocar guide tube ofdiameter of about 12 mm for example. The stack of staples 110 as shownin FIG. 18 is positioned and retained in such position by a resilientspring member 113 having dual resilient legs and whose side profile iscurved as shown in FIG. 18.

The distal end of each leg engages the uppermost staple follower 114 inthe form of a nylon insert having a general “H-shaped” configuration anddimensioned sufficient to cover the staples as best shown in FIG. 15.The nylon follower is intended to transmit the downward force of thestaple retainer spring 113 so as to distribute the force on the stack ofstaples in a manner to facilitate a constant and uni-directionaldownward force on the lowermost staple which is positioned foradvancement and deformation. It also functions to advance the stack ofstaples downwardly when the lowermost staple is fired. Steel anvil plate120 is shown in FIG. 15 and includes upwardly extending feet 116 and 118which form anvils at the distal end as shown in FIG. 15, for forming thestaple therearound.

Thus, as seen in FIG. 18, the lowermost staple is identified by numeral110L and is in a position for engagement by pusher plate 104 when thepusher assembly is advanced distally. The pusher plate 104 is shownclearly in FIGS. 15 and 18 and contains distally advancing lands 104Rand 104L shown clearly in FIGS. 15 and 19 at the distal end tofacilitate transmission of advancing force to the two rounded or arcuatebridge portions of the staple. This relative complementary configurationof the pusher plate 104 and the staple 110 facilitates efficient anduniform distribution of force to the staple when it is deformed aboutthe anvil members as will be described.

The Staple Closing System

Referring now to FIGS. 17-24 there is illustrated the sequential viewsof the staple advancing and closing system between the pre-fired andfired condition of the staple. In particular, the staple and pushermechanism are shown in FIG. 17 in the pre-fired condition while thestaple shown in FIG. 24 is embedded within the body tissue in a mannerto retain the surgical mesh to the body tissue.

In FIG. 17, the staple pusher assembly 24 is positioned proximal of thelowermost staple 110L and pusher plate 104 is correspondingly positionedproximal of the lowermost staple 110L. In FIGS. 18 and 19 the pusherplate 104 has been partially advanced distally and the lowermost staple110L has been advanced distally of the stack of staples 110 in a mannersuch that the pusher plate 104 has now replaced lowermost staple 110Lthereby preserving the integrity and position of the stack of staples110. The preservation of the stack of staples 110 is provided by thefact that the thickness of the staple pusher plate 104 is eitheridentical to or slightly less than the thickness of the staples toassume that the plate 104 will engage only one staple at a time.

Referring further to FIGS. 20 and 21 the pusher plate 104 has nowadvanced distally sufficient to cause the staple to penetrate thesurgical mesh 112 and the body tissue 114. As shown in FIGS. 20 and 21,it can be seen that anvil members 116 and 118 are positioned forengagement by the straight sections of bridge portions 110BR and 110BLof the back rib of the staple 110L such that engagement of the staple bypusher plate 104 with the arcuate end corner portions of the staple asshown will cause the staple to deform in a predetermined manner as willbe described.

In FIGS. 22-24 the staple 110L is now shown in the deformed conditionabout the anvil members 116 and 118 and the straight portions 110S ofthe back rib of the staple 110 are still in engagement with the anvils116,118. In FIG. 22, the staple has penetrated into the body tissue 114and has been deformed and in FIG. 24 the staple deformation is completedin a manner to substantially retain the surgical mesh 112 in attachedposition with respect to the body tissue as shown in FIG. 22. Theinwardly projecting central portion or bight, 110C, of staple 110 isshown gripping the mesh and tissue in cooperation with the staple legsas shown in FIG. 24. However, release of the staples from the anvilmembers 116,118 has not yet been completed.

Release of the staple from the anvil members 116,118 is readilyaccomplished by ejector spring 124 which is a “U-shaped” resilientspring having upwardly biased legs 124R and 124L each positionedrespectively as shown in FIG. 15. When the pusher plate 104 is in theposition shown in FIG. 20, the legs 124R and 124L of staple ejectorspring are retained in a downward position by lands 104R and 104L of thepusher plate 104. However, when the pusher plate 104 is moved to thedistalmost position shown in FIG. 23, the absence of the pusher platepermits staple ejector legs 124R and 124L to resiliently deflectupwardly to their natural configuration thereby creating a verticalseparation between the anvil members 116,118 and the deformed staple,thus releasing the deformed staple from the anvil members as shown inFIG. 23. Continued proximal movement of the pusher plate 104 causeswithdrawal of the pusher plate to a position entirely proximal of thestack of staples 110 as shown in FIG. 26, causing the stack of staplesto move downwardly due to the downward force of resilient stapleretainer spring 113 to advance the lowermost staple to the firingposition.

Once the staple 110 is applied to the mesh 112 and tissue 114 as shownin FIGS. 22 and 24, the distal end of staple storing magazine 16 iswithdrawn as shown in FIG. 24 and preparation is made for application ofthe next staple. FIG. 25 is a cross-sectional view taken along lines25-25 of FIG. 24 with the staple storing magazine withdrawn from thesurgical mesh and body tissue. Thereafter, the apparatus may berepositioned to apply another staple, or even an array of staples asshown in FIGS. 27 and 29.

Referring once again to FIG. 27, there is illustrated one form ofsurgical mesh repair of an opening in the body utilizing the apparatusand staple according to the invention. In the application shown in FIG.27, a surgical mesh is attached to the body tissue over the opening asillustrated schematically at 114 c in FIG. 27, and staples 110 have beenapplied in a circular array as shown to reinforce the repair. Beneaththe mesh, the opening 114 c may have previously been repaired as well.In FIG. 29 an alternative array of staples to apply mesh material tobody tissue is shown. In this embodiment the mesh material 112 isessentially formed as a circular patch and staples 110 are oriented in aradial direction and are attached around the periphery of the patch suchthat one leg of the staple pierces the mesh and the other leg piercesbody tissue 114. Essentially the staple bridges the periphery of themesh material as shown. Clearly, alternative forms and arrangements areavailable to attach mesh or other surgery related objects or prosthesesto body tissue as may come to the mind of persons skilled in the art.

It should be further noted that the repair of body tissue utilizingsurgical mesh as shown in FIGS. 27 and 29 are exemplary, and that otherapplications of mesh and staples may be utilized in a manner to eitherreinforce a surgical repair or to encourage tissue growth. Such meshmaterials are typically disclosed in U.S. Pat. Nos. 4,838,884,4,665,221, 4,452,245, and 4,347,847. It is noted that the stapleconstructed according to the invention as shown in FIG. 28 isparticularly adapted for attachment of such mesh material to body tissueaccording to any number of techniques which may readily come to the mindof those skilled in the art. In fact, in some instances the mesh may beformed as a plug for insertion into a surgical opening and then stapled.Moreover, the apparatus and staple of the present invention may beapplied to attach other objects to body tissue as may come to the mindof those skilled in the art.

The Staple

Referring now once again to FIG. 28, there is illustrated the inventivestaple 110 constructed according to the invention. The staple 110 isparticularly shaped as shown, and is preferably formed of a length ofwire of titanium. Stainless steel or equivalent material is alsocontemplated and the staple preferably has a rectangular cross-sectionas shown. Other cross-sections may be used. Typically, the wire will beabout 0.38 mm in width (dimension w) and 0.51 mm in thickness (dimensionT). The initial width of the staple before closure (dimension A) isabout 4.4 mm and the thickness dimension between the back rib and legsafter closure (i.e. dimension B in FIG. 24) is about 3 mm. Anotherexample is a wire having a width of about 0.51 mm (dimension W) and athickness of about 0.38 mm (Dimension T). The width before closure(dimension A) is about 8.64 mm and the thickness between the back riband legs after closure is about 2.5 mm (dimension B in FIG. 24). Thestaple 110 has a central bight portion 110 c and a wire leg member 110Rand 110L extending generally perpendicular to the central portion asshown. Each leg member 110R, 110L is connected to the central portion110 c by a bridge portion 110BR, 110BL having an arcuate corner portionas shown. Each leg member has a sharp tip for penetrating mesh and bodytissue. Right leg member 110R further possesses a tapered surface 110TRat the tip which is opposite the position of the tapered surface 110TLat the tip of the other leg member 110L as shown in FIG. 28.

When the staple shown in FIG. 28 is advanced toward dual spaced anvils116,118 as shown in FIG. 21 for example, and staple pusher plate 104 asshown, engages the arcuate portions of the bridge portions 110BR and110BL, the legs of the staples are made to fold inwardly toward eachother as shown for example in FIG. 22, with one leg crossing over theother. The cross-over configuration is automatically assumed by the legsbecause of the presence of tapered surfaces 110TR and 110TL which act ascamming surfaces tending to bias each leg away from the other therebytending to cross the legs in the manner shown. This structure alsoprevents interference of the legs when folded toward each other.

Thus, it can be seen that the particular shape of the staple as shown,promotes a unique folding pattern for the legs which achieves theconfiguration shown in the bent staples of FIGS. 22 and 24. Note inparticular that inwardly bent central portion 110 c promotes positiveattachment of the mesh to the tissue by providing a gripping systembetween inwardly projecting bight portion 110 c and leg members 110R and110L with mesh and tissue gripped therebetween. This staple shapecombines with the arrangement of the anvils and the particularlyconfigured pusher plate 104 to cause the staple to pierce mesh and bodytissue up to a predetermined extent. At this point, continuedapplication of force to the staple causes the staple legs to fold uponthemselves as shown in the drawings while encompassing a sufficientportion of the mesh to attach the mesh to the body tissue. Thus thestaple pieces folds and grips in substantially a single movement.

In practice, the laparoscopic procedures to repair tissue in herniarepair using surgical mesh is similar in some respects to the surgicalprocedures to gall bladders, appendix, lungs, etc. In particular, theendoscopic tubular section of the apparatus is inserted into the cannulawhich is positioned within the opening in the body. Provision is madebetween the cannula and the endoscopic section to seal the connectiontherebetween and provision may also be provided to seal the actualendoscopic apparatus from leakage of fluids or insufflating gaseousmedia. An exemplary cannula assembly including seal means is disclosedfor example in commonly assigned U.S. Pat. No. 4,943,280, issued Jul.24, 1990, the disclosure of which is incorporated herein by reference.

The Kit

The present invention is readily adaptable to be provided to surgeons inthe form of a kit in which all necessary equipment and accessories areprovided in sterile form ready for use in surgery. For example, anapparatus constructed according to the invention can be readily packagedwith a supply of staples (i.e. up to 12 or more staples) and sufficientmesh material for completing the hernial repair. The mesh material istypically about 1 mm in thickness. The components may be providedseparately as a matched kit, or in a blister type or other package,suitable and ready for use by the surgeon and the surgeon's assistants.The apparatus and staples can be provided in any size matched to meetthe apparatus and mesh material in accordance with the particular needsof a contemplated hernial surgical procedure. In addition, the kit caninclude a matching trocar assembly with appropriate valve assembly toprevent loss of the insufflating gas from the peritoneum between thetrocar and the outside surface of the endoscopic section. Since theouter housing of the endoscopic section is substantially closed at thepoint of attachment of the staple magazine, release of insufflatinggases through the staple magazine and the endoscopic section housing iseither non existent or minimal. Such trocar assembly is available fromUnited States Surgical Corporation, Norwalk, Conn., under the trademarkSURGIPORT brand trocar assembly.

A typical endoscopic section may be a 12 mm diameter with a staplemagazine capable of holding up to 10 staples of appropriate size. Thelength of the endoscopic section is typically 14 to 15 inches. Anendoscopic section in the embodiment shown will be about 14 inches.However, if pivotal movement of the staple storage magazine is to beprovided between plus 45 degrees and minus 45 degrees solely by distaland proximal movement of collar 22, the endoscopic section will bestructured to greater in length, i.e. about 15 inches. The trocarassembly will be of matching size, i.e., 12 mm, to accommodate theendoscopic section and to prevent release of gases thereby. The meshmaterial provided with the kit will be of mesh size comparable for usewith the size of the staples provided in the kit.

Thus by structuring the apparatus to provide such sealing, theendoscopic application of staples to attach objects such as surgicalmesh to body tissue can be readily accomplished. Accordingly, thepresent invention is not only directed to the apparatus for applyingsuch staples to body tissue, but also to a kit in which the apparatus isuniquely combined with a supply of staples, surgical mesh, cannulaassembly etc. whereby the surgeon may readily perform the necessaryprocedures.

An Alternative Embodiment

In the following description of an alternative embodiment of theinvention, like components will be identified by numerals similar to thenumerals for like components in the previous embodiments except thatthey will be preceded by the numeral “2”. Accordingly, for example, theentire apparatus of the previous embodiment was identified in thedescription as numeral “10”. In FIG. 30, for example, the apparatus isidentified by numeral “210”.

Referring now to FIG. 30, there is illustrated a perspective view of analternative embodiment of the apparatus constructed according to theinvention in which the staples are stored in a cartridge which isself-contained and which is readily insertable at the distal portion ofthe endoscopic section of the apparatus as shown in FIG. 33. Theapparatus 210 includes handle portion 212 and endoscopic section 214having at the distal end portion a staple storage cartridge supportmeans 266 on which is supported staple storage cartridge 216. Generally,it may be stated that the staple cartridge support member 266 ispivotally mounted to the distal portion of the endoscopic section andsuch pivotal motion will result in similar pivotal motion of the staplestorage cartridge 216 since the cartridge is directly supported by thepivotal support member. The pivotal motion of the staple storagecartridge support member and related mechanism is identical to themechanism described previously in connection with the first embodiment.

Referring now to FIG. 31 the components which form the handle 212 areshown and are in many respects identical to the components and functionof the handle shown in FIG. 2. The handle components shown in FIG. 31,however include an additional feature which provides a manual tactilefeel to assist the user in knowing when the staple is at a particularvisible position shown in FIG. 39. One way this can be achieved is shownin FIG. 31 whereby arcuately shaped notch 233 is incorporated into thetriangular member 234 and is configured and dimensioned similar to thepin 236. When trigger 220 is manually squeezed by the user towardupright member 235 causing horizontal pin 236 to traverse an upward arcas described in connection with the previous embodiment the pin 236engages the longer side 234 a of triangular member 234. Thus, each timethe trigger 220 is squeezed a sufficient distance, the pin 236 willenter arcuately shaped notch 233 so as to provide the user with anactual indication by feel of the location of the pin with respect to thelonger side 234 a of triangular member 234. At this point along the pathof pin 236 the staple 210, next in line, will be at the same partiallyadvanced distal location which is shown in FIG. 39. Thus, when the usersenses or feels the detent of the entry of pin 236 into notch 233 anactual perceptible tactile indicator of the position of the staple nextin line is thus provided. This partially advanced position of the staplefacilitates visual examination of the staple to assist the user inselecting the proper position or location and/or orientation which wouldbe appropriate for the particular staple application which is inprogress. At all times, however, while trigger 220 is being squeezed,the uni-motion clutch mechanism 200 will prevent retracement of thetrigger until the full stroke has been completed, as describedpreviously. It should be noted that other means, including visible andaudible, can be utilized to achieve the advantageous provision ofindicating to the user when the staple is in its partially advancedposition.

Referring now to FIGS. 32 and 32A, the unique replaceable staplecartridge system constructed according to the present invention isdisclosed. In contrast to the embodiment described hereinabove thestaple storage magazine and pivoting system has been replaced by thecombination of a replaceable staple storage cartridge 216 shown withparts separated in FIG. 32A and a pivotal staple cartridge supportsystem 215 shown with parts separated in FIG. 32. In summary, thepivotal staple cartridge support system is permanently attached forpivotal movement via pins 289 with respect to the endoscopic section 210and the cartridge 216 is readily insertable with respect to the supportsystem as shown in FIG. 33.

Referring once again to FIG. 32 the staple cartridge support systemincludes support member 266 having proximal upper face member 215permanently attached thereto by ultrasonic welding, gluing etc. Theentire assembly is attached for pivotal movement to endoscopic section210 via pins 289. As described in the previous embodiment the pivotalmovement of the staple cartridge support member 266 and relatedcomponents is capable of extending up to about 45° with respect to thecentral axis of the endoscopic section 210. However, as noted previouslythis cartridge support system may be arranged to pivot from about +45°to about −45° by dimensioning the pivoting system appropriately.

The pivotal movement of the staple cartridge support system shown inFIG. 32 is identical in all respects to the pivotal movement of thestaple storage magazine described in connection with the previousembodiment and shown particularly in FIG. 15. However, in the staplecartridge support system in FIG. 32 the structure has been modified asshown to accommodate the removable and replaceable staple cartridge 216.For example, at the distal end portion of the staple cartridge supportsystem there is shown cartridge support plate 217 which includes a lip217 a at the proximal end for reception of the distal tips 216 a of thecartridge housing to retain the cartridge 216 in position on the supportmember 266. In addition cartridge support plate 217 includes distallyextending leg members 217 b which in turn include tip portions 217 cwhich extend distally of the tip of cartridge support member 266 asshown more clearly in FIG. 33. The tip members 217 c extend not onlydistally but also inwardly as shown clearly in FIGS. 32 and 34 so as toprovide an increased staple contact surface and backing support for eachstaple as it is advanced distally and as it is deformed. This featureprevents the staple from curling rearwardly as it is being deformed inthe event such tendency may be present. Thus, this feature providesresistance to backward roll for each staple.

Referring once again to FIG. 32 a and FIG. 32 b the cartridge 216 isshown and is assembled to contain a plurality of staples which arepreloaded and a spring 213 having distally extending legs 213 a adaptedto bias staples 210 in a direction toward the anvil 220 via staplefollower 214 constructed of a suitable material such as nylon. Thestaples are contained in cartridge 216 by “L” shaped holders 216 g onthe lower face of the cartridge 216 as shown in FIG. 32B. In the presentembodiment, the staple follower 214 is similar to staple follower 114 ofthe previous embodiment but contains a proximally extending extension214 a terminating in head 214 b which extends into the space 213 bdefined by the legs 213 a of spring 213.

The cartridge 216 is inserted into position as shown in FIG. 33 and isretained by positioning distal tips 216 a into respective spaces 217 eformed on each side between face member 215 and cartridge support member266. Central partition 217 d becomes positioned within the space 216 kbetween cartridge distal legs 216L to stabilize the cartridge inposition. Downwardly extending cartridge legs 216 h shown more clearlyin FIGS. 34, 35 and 36 are configured as shown, to resiliently snap intoelongated apertures 215 a in face member 215 as shown in FIG. 36 toretain the cartridge in position when it is rotated thereinto in thedirection of arrow A as shown in FIG. 33. Thus, it is preferable tofabricate the housing of cartridge 216 of a resilient plastic material.

The operation of the staple follower 214 is clearly illustrated in FIGS.35 through 38. In FIG. 35, the staple cartridge 216 is shown with a fullcomplement of staples 210 and the proximal portion 214 a of staplefollower 24 is shown extending upwardly through the legs 213 a of spring213. A window 216 c is provided in the upper housing 216 b of cartridge216 to facilitate visibility of the staple follower when all stapleshave been spent and the proximal head 214 b of staple follower 214 movesupwardly into the window 216 b as shown in FIG. 38, by the action ofspring 213. Thus, the user is provided with an immediate visibleindicator when all staples have been spent.

In addition, it is desirable to fabricate staple follower 214 of abright colored plastic material such as nylon. For example, follower 214could be fabricated of a bright yellow material at least at the head 214b such that a visible indication will be provided by head 214 b afterthe last staple has been spent. In assembled condition, the head 214 band extension 214 a will be positioned in space 213 b between legs 213 aof spring 213 as shown in FIGS. 35 and 38. In addition, it is desirableto color the area 216 d of upper housing 216 b of the cartridge 216 in acolor similar to the color of the extension 214 a of follower 214. Forexample, follower 214 may be colored black in its entirety with theexception of head 214 b which would be colored bright yellow.

The area 216 d of the upper housing 216 b (shown by the stippledportions in FIGS. 32A and 34) can also be colored black. Thus, when afull complement of staples 210 is provided as in FIG. 35, the blackportion of extension 214 a of follower 214 will appear through window216 c and this black color will complement the black colored area 216 dshown by stippling in FIG. 34. Follower 214 is fabricated of a resilientmaterial such as nylon and is configured to be upwardly biased againstthe inner ceiling 216 j as the staples are individually dispensed. Whenthe last staple has been dispensed and closed as shown in FIG. 38, theyellow colored head 214 b of follow 213 will snap upwardly under its ownresilience to thereby appear through window 216 c and the user willtherefore be provided with an immediate visible indication that the laststaple has been spent. Thereafter, the cartridge may be simply removedby lifting it away from the pivotal support member 266 in the directionopposite the direction shown by the arrow A shown in FIG. 33. Thecartridge may be replaced by a fully loaded cartridge and the surgicaloperation may proceed.

Another feature of the cartridge of the present invention is theprovision of colored circular dots 216 e and 216 f. One of each suchcircular dot is shown on upper cartridge housing 216 b by circlessurrounded by stippled areas in FIGS. 32A and 33. By placing the user'sthumb and first middle finger on the two dots 216 e on each side of theupper housing 216 b, and the index finger on the forward dot 216 f, thecartridge may be simply lifted from the pivotal support member 266causing cartridge legs 216 h to release their snap grip on face member215. Thereafter, a full cartridge may be replaced in the same, butreverse fashion by positioning tips 216 a into space 217 e and snappinglegs 216 h into position with apertures 215 a. The circular dots 216 eand 216 f can be provided in any suitable color which is readilyobservable to the user. For example, these circular dots may be providedin the color black, which would be readily visible in contrast to theyellow indicator of head 214 b of staple follower 214.

Referring now to FIG. 40, there is illustrated a circular sleeve 270similar to the circular sleeve 70 shown in FIG. 13 in connection withthe previous embodiment. The circular sleeve 270 is identical in allrespects to the cylindrical sleeve 270 of the previous embodiment and isconfigured as a camming surface adapted to engage push rods 276, 278 topivot the cartridge support member 266 and the staple cartridge 216 inthe same manner as described in connection with the previous embodiment.In FIG. 40 grooves 270 a and 270 b are illustrated to provide a positivestop which corresponds to the engagement of push rod 276, 278 withgrooves 270 a and 270 b when the staple storage cartridge support system266 is in the pivotal position, i.e. approximately 45° with respect tothe endoscopic section. The positive stop which is provided by theengagement of the push rods 276, 278 with the grooves 270 a and 270 b isidentical to the operation of sleeve 70 described in connection with theprevious embodiment. However, optionally additional grooves 270 c and270 d may be provided in sleeve 270 corresponding to pivotal locationsof the cartridge support member 266 which are less than the full pivotalmovement of the support system, i.e. 25°. These optional grooves willfacilitate providing a perceptible tactile indication to the user of thelocation of the cartridge and related support system in terms of pivotalangle with respect to the endoscopic section. Optionally any number ofsuch grooves may be provided dependent upon the particular needs of theuser and the particular surgical procedures required. Thus, theinstrument may be provided with any number of combinations of theabove-described features.

FIG. 41 is a cross-sectional view taken along lines 41-41 of FIG. 30,illustrating schematically a gaseous seal means in the form of siliconegrease 250 to prevent the insufflating gaseous media from escaping fromthe patient's body cavity through the instrument. Such gaseous sealmeans may alternatively be in the form of a separate seal blockpositioned within the endoscopic section, or it may alternatively be inthe form of a gaseous sealing block located either in another portion ofthe endoscopic section or alternatively in the handle section.

The present embodiment may be incorporated into kit form as in thepreviously described embodiment. Also, combinations of features of thepresent embodiment may be combined with features described in connectionwith the previous embodiment as may become apparent to persons skilledin the art.

1. A surgical instrument comprising: an elongate member defining alongitudinal axis; an end effector pivotably coupled to a distal end ofthe elongate member; and an articulation mechanism operably coupled tothe end effector, the articulation mechanism including: a collar movablymounted on the elongate member, and first and second rods operativelycoupling the collar to the end effector such that axial movement of thecollar along the longitudinal axis urges the first rod in a proximaldirection and the second rod in a distal direction, thereby pivoting theend effector relative to a longitudinal axis of the elongate member. 2.The surgical instrument of claim 1, wherein the end effector ispivotable throughout a plurality of positions relative to thelongitudinal axis of the elongate member.
 3. The surgical instrument ofclaim 1, wherein the collar is movable along the elongate member from afirst position to a second position.
 4. The surgical instrument of claim1, further including a cartridge having at least one fastener, thecartridge being removably attached to the end effector.
 5. The surgicalinstrument of claim 4, wherein the end effector is pivotable throughouta plurality of positions including a first position that is aligned withthe longitudinal axis and a second position that is axially offset fromthe longitudinal axis.
 6. The surgical instrument of claim 5, whereinthe at least one fastener is longitudinally translatable through thecartridge in each position of the plurality of positions.
 7. Thesurgical instrument of claim 1, wherein the articulation mechanismfurther includes a first sleeve disposed within the collar forconcomitant rotation with the collar, the first sleeve defining ahelical groove, and a second sleeve disposed within the first sleeve,the second sleeve having a pin extending radially outward, the pinconfigured for slidable movement within the helical groove of the firstsleeve such that the longitudinal movement of the collar causes the pinto follow the groove causing the second sleeve to rotate in onedirection.
 8. The surgical instrument of claim 7, wherein the secondsleeve includes a obliquely oriented distal face, the face engagingproximal ends of the first and second rods, such that when the collar ismoved longitudinally, the second sleeve rotates causing the first andsecond rods to move in opposite directions.